Glenmark gets USFDA approval for Theophylline ER tablets

Pharma major Glenmark Pharmaceuticals Ltd on Friday said it has received the final approval by the US Food and Drug Administration (USFDA) for Theophylline extended release (ER) tablets, 300 mg and 450 mg.

The company said the tablet is the bioequivalent and therapeutically equivalent to the Theophylline extended-release tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited.

It is used to treat wheezing, chest tightness due to asthma, lung diseases and others for easier breathing.

Glenmark has been granted a competitive generic therapy (CGT) designation for Theophylline extended-release tablets USP, 450 mg.

As such, it is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing of the 450 mg strength.

According to IQVIA sales data for the 12 month period ending April 2021, the Theophylline extended release tablets, 300 mg and 450 mg market achieved annual sales of approximately $47.8 million.